Iopromide

ULTRAVIST ® Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures † • Cerebral arteriography and peripheral arteriography in adults. • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults. • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older. Intravenous Procedures † • Excretory urography in adults and pediatric patients aged 2 years and older. • Contrast computed tomography (CT) of head and body in adults and pediatric patients aged 2 years and older. • Contrast mammography in adults as an adjunct following mammography and/or ultrasound † Specific concentrations and presentations are recommended for each type of imaging procedure.

Intravascular injection of iopromide opacifies those vessels where the contrast agent is present, permitting radiographic visualization of the internal structures through attenuation of photons. In imaging of the body, iodinated contrast agents diffuse from the vessels into the extravascular space. In normal brain with an intact blood-brain barrier, contrast does not diffuse into the extravascular space. In patients with a disrupted blood-brain barrier, contrast agent accumulates in the extravascular space in the region of disruption.

• Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel. • For contrast mammography, use ULTRAVIST with a device that is cleared for dual-energy full field digital mammography. • See full prescribing information for important dosage and administration instructions and directions for use of pharmacy bulk packages and imaging bulk packages.

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Boxed warning (not for intrathecal use warning: not for intrathecal use): Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is not approved for intrathecal use. • Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. • Acute Kidney Injury: Acute injury including renal failure can occur. Dose minimization and hydration may decrease risk. • Cardiovascular Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. • Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity

The following adverse reactions are described elsewhere in the labeling: • Risks Associated with Intrathecal Use • Hypersensitivity Reactions • Acute Kidney Injury • Cardiovascular Adverse Reactions • Thromboembolic Events • Extravasation and Injection Site Reactions • Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age • Severe Cutaneous Adverse Reactions Common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision.

Drug-Drug Interactions Metformin In patients with renal impairment, biguanides can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, ULTRAVIST administration in patients with an eGFR between 30 and 60 mL/min/1.73 m2, in patients with a history of hepatic impairment, alcoholism, or heart failure, or in patients who will be administered intra-arterial iodinated contrast agents. Re-evaluate eGFR 48 hours after the imaging procedure and reinstitute only after renal function is stable. Radioactive Iodine ULTRAVIST may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post ULTRAVIST.

Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.